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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Version history

Version history: Recall procedure
Version Description of change Author Effective date
V1.0 Publication for consultation Therapeutic Goods Administration 27 October 2015
V2.0 Original publication incorporating feedback from consultation

Recalls and Case Management Section

Regulatory Guidance Team

Publication date: October 2017

Implementation date: 15 January 2018

V2.1 This version of the URPTG includes clarifying amendments in relation to the new (January 2018) requirements for 'quarantine' actions and introduces a more flexible approach for 'consumer recall notices' required as part of conducting consumer level recalls. (These 'notices' were formerly referred to as 'recall advertisements'). Recalls Section February 2019

This version of the URPTG includes:

  1. additional clarity on the provision of surgeon contact details for implanted therapeutic goods
  2. amendments related to the online notification of recall and non-recall actions.
Recalls Section December 2019

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